Effect of Nutritional Intervention Based on Prediction Model on Adult Umbilical Cord Blood Transplantation Patients

NCT06553274 | Not Yet Recruiting Phase 2

• 1 other identifier: Nutrition-2024
• Study Type: interventional
• Target: 67
• Locations: 1 country
• Sites: 1

Brief Summary

Based on the nutritional factor prediction model, the individualized nutritional management of patients with umbilical cord blood transplantation (UCBT) was carried out to observe the impact on the survival efficacy of patients.

Conditions

Nutrition Disorders

Keywords

umbilical cord blood transplantation; nutrition intervention

Outcome Measures

Primary Outcomes (6)

• The body mass index

  Body Mass Index (BMI) is defined as a person's weight in kilograms divided by the square of their height in meters (kg/m²).

  before transplantation, Day30 , Day 60 , Day120 , Day180, 12 months after transplantation.

• The calf circumference

  The calf circumference (cm)

  before transplantation, Day30 , Day 60 , Day120 , Day180, 12 months after transplantation.

• The thickness of skinfold

  thickness of skinfold (mm)

  before transplantation, Day30 , Day 60 , Day120 , Day180, 12 months after transplantation.

• Grip strength

  The grip strength (kg)

  before transplantation, Day30 , Day 60 , Day120 , Day180, 12 months after transplantation.

• Prealbumin level

  The level of prealbumin (mg/L)

  before transplantation, Day30 , Day 60 , Day120 , Day180, 12 months after transplantation.

• Albumin Level

  The level of Alb (g/L)

  before transplantation, Day30 , Day 60 , Day120 , Day180, 12 months after transplantation.

Secondary Outcomes (7)

• Incidence of complications

  before transplantation, Day30 , Day 60 , Day120 , Day180, 12 months after transplantation.

• Overall survival (OS)

  12 months after transplantation

• Disease-free survival (DFS)

  12 months after transplantation

• The cumulative incidence of relapse (CIR)

  12 months after transplantation

• Non-Relapse Mortality (NRM)

  12 months after transplantation

Study Arms (1)

Individualized nutrition intervention

EXPERIMENTAL

Full-time clinical nutrition pharmacists evaluate the nutritional status of enrolled patients and design individualized nutrition management programs

Procedure: Individualized nutrition intervention

Interventions

Individualized nutrition intervention PROCEDURE

After the patients were enrolled, they were given nutritional assessment by full-time clinical nutritionist and designed individualized nutritional management program, which included: Nutritional Assessment once a week for 4 weeks after Transplantation + 30 days, and nutritional assessment once a week for 4 weeks after Transplantation + 60 days, nutritional assessment every 2 weeks for 8 weeks; nutritional assessment every 4 weeks for 1 year after Transplantation + 120 days after transplantation; nutritional assessment during hospitalization in the ward and after discharge from the hospital, they were followed up in the nutrition counseling clinic or by telephone. The total energy intake was 25-35 kcal/kg/d and the protein intake was 1.2-1.5 g/kg/d. According to the"Five-step nutritional treatment principle", individual nutritional prescriptions were designed by clinical nutritionists.

Individualized nutrition intervention

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-65 years old, conscious, with language communication skills;
• UCBT patients to be performed;
• Major organs without serious dysfunction;
• The participants agreed to participate in the study and signed the informed consent form.

You may not qualify if:

• Age \< 18 years old or \> 65 years old or with cognitive impairment can not complete this survey;
• Failure or recurrence of transplantation;
• Combined with severe other organ system diseases (such as severe cardiac insufficiency, autoimmune disease, active infection, severe trauma) ;
• Patients who have difficulty collecting data to complete the nutritional intervention;
• Patients who asked to withdraw from the study.

Sponsors & Collaborators

• Anhui Provincial Hospital: lead

Study Sites (1)

The First Affiliated Hospital of University of Science and Technology of China (Anhui Provincial Hospital

Hefei, Anhui, 230041, China

Location

MeSH Terms

Conditions

Nutrition Disorders

Condition Hierarchy (Ancestors)

Nutritional and Metabolic Diseases

Study Officials

• Xiaoyu Zhu, Ph.D

  The First Affiliated Hospital of University of Science and Technology of China

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiaoyu Zhu, Ph.D

CONTACT

15255456091; xiaoyuz@ustc.edu.cn

Lijuan Ning, M.D

CONTACT

13866106561; ninglijuan621@126.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: Based on the nutritional factor prediction model, the individualized nutritional management of patients with umbilical cord blood transplantation (UCBT) was carried out to observe the impact on the survival efficacy of patients.

Study Record Dates

• First Submitted: August 5, 2024
• First Posted: August 14, 2024
• Study Start: August 1, 2024
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: August 14, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)